Distance Education Versus Usual Care Qualification in Asthma Care (RESPIRANET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
Karine Margarites Lima, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01595971
First received: May 9, 2012
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

The purpose of this study is to evaluate the effectiveness of multifaceted educational interventions in the care of asthma, conducted remotely over the platform TelessaúdeRS in teams of the Family Health Strategy and the consequent clinical improvement patients.


Condition Intervention
Asthma
Behavioral: Continuing education
Other: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Distance Education Versus Usual Care in the Qualification of Asthma Care: A Cluster Randomized Clinical Trial - RESPIRANET

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Symptom burden, measured as the number of self-reported asthma symptom days (ASD). ASD is based on 2 week recall. [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    The definition of a symptom day includes presence of any of the four types of asthma symptoms: wheeze, cough, night time awakening ou shortness of breath. The results will be collected through the application of standardized questionnaires.


Secondary Outcome Measures:
  • Asthma control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Control of asthma will be evaluated by the excessive use of relief medication in the last month.

  • Health care utilization [ Time Frame: 6 meses ] [ Designated as safety issue: No ]
    Proportion of unscheduled medical visits during the follow-up

  • Proportion of patients in use inhaled corticosteroids [ Time Frame: 6 meses ] [ Designated as safety issue: No ]
    Use of inhaled corticosteroids assessed by the proportion of patients who require medication to prevent asthma symptoms that are in use of inhaled corticosteroids.


Enrollment: 467
Study Start Date: August 2010
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: continuing education
RESPIRANET is a multifaceted intervention directed at professionals of the Family Health Teams in the inner cities.Includes telemedicine, reminders, video conferences, educational materials for patients and consultants.
Behavioral: Continuing education
Includes telemedicine, reminders, video conferences, educational materials for patients and consultants.
Other Name: RESPIRANET
Placebo Comparator: Usual Care Other: usual care
Received the usual care provided

Detailed Description:

Cluster-randomized trial with follow-up of 6 months. The aim of this study is to determine whether multifaceted interventions performed at a distance for the care of asthma symptoms reduce overhead, improve asthma control and qualify the care provided to patients.

  Eligibility

Ages Eligible for Study:   5 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Practice:Participate in the Telessaúde/RS. Minimal staff consisting of a general practitioner, nurse, nurse and community health agents (CHA), ability to give at least ten patients diagnosed with asthma, located in a municipality to make available for free inhaled medication (short-acting bronchodilators and corticosteroids ) for the treatment of asthma and willingness to participate in the study.
  • Patients: 5 to 45 years with a diagnosis of asthma made ​​by a physician and register at least one consultation for asthma or an asthma-related hospitalization during the year preceding the beginning of the study.

Exclusion Criteria:

  • Patients with other chronic diseases with pulmonary complications such as tuberculosis, cancer and cystic fibrosis or those with severe mental illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595971

Locations
Brazil
Hospital de clínicas de Porto Alegre
Porto Alegre, Rio grande do sul, Brazil
Sponsors and Collaborators
Karine Margarites Lima
Federal University of Rio Grande do Sul
Investigators
Study Chair: Erno Harzheim, PHD Federal University of Rio Grande do Sul
  More Information

Additional Information:
No publications provided

Responsible Party: Karine Margarites Lima, MD, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01595971     History of Changes
Other Study ID Numbers: MED/FNS 774/08
Study First Received: May 9, 2012
Last Updated: May 9, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Asthma
Continuing education
Primary health care

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014